Enteric Coated Aspirin by Rugby Laboratories, Inc / Time Cap Labs, Inc Rugby 331R

Enteric Coated Aspirin by

Drug Labeling and Warnings

Enteric Coated Aspirin by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc, Time Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ENTERIC COATED ASPIRIN- aspirin tablet, delayed release 
Rugby Laboratories, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rugby 331R

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves

• headache
• muscle pain
• menstrual pain
• toothache
• minor pain of arthritis
• pain and fever of cold

Warnings

Reye's syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:

Aspirin may cause a severe allergic reaction which may include

• hives
• shock
• facial swelling
• asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user

• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• takes more or for a longer time than directed
• has 3 or more alcoholic drinks every day while using this product
• is age 60 or older

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

• adults and children 12 years and over: 1 - 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
• children under 12 years: ask a doctor

Inactive ingredients

corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

ENTERIC COATED ASPIRIN 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-3313
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-3313-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2011	01/01/2018
2	NDC: 0536-3313-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2011	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	09/20/2011	01/01/2018

Labeler - Rugby Laboratories, Inc (079246066)

Registrant - Time Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Labs, Inc		037052099	manufacture(0536-3313)

Revised: 11/2019

Document Id: 9855efa4-bfa0-392c-e053-2a95a90a8a5a

34390-5

Set id: 56c087e9-bfca-4b28-838a-5036b487e151

Version: 2

Effective Time: 20191127

 

Rugby Laboratories, Inc